QA Specialist

QA Specialist IIIReview batch records and documents pertaining to batch records. Required years of experience: 6-10 years. Top three required skill sets: batch record review experience, experience with deviations, clinical or commercial experience. Top three nice to have skill sets: accountable, detail oriented, proactive. Unique selling point of this role: opportunity to work with new programs. Required degree or certification: BA or BS. Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Participates in developing Standard Operating Procedures to ensure quality objectives are met. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products. Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required. Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. May facilitate external audits/inspection processes, supporting implementation of corrective actions as agreed. Participates in the writing of annual product reviews. May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. Works with Research and Development during new product start-ups, and identifies routine checkpoints for new products and processes. May assist with compliance audits as required. Interfaces with contract manufacturers to address documentation and compliance issues. Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed. Normally receives no instruction on routine work, general instructions on new assignments.